Last updated: November 3, 2023
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Hyponatremia
Congestive Heart Failure
Chest Pain
Treatment
Placebo
Carvedilol
Clinical Study ID
NCT05553314
CARE-preserved HF
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age ≥20 yrs
- symptomatic HFpEF with LVEF≥50%
- NT-proBNP ≥220 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥80 pg/ml (sinus rhythm) or ≥240 pg/ml(AF) )
- SBP≥140mmHg and/or DBP ≥90mmHg, or if taking anti-hypertensive medication, SBP ≥110mmHg.
- LAVI≥29(sinus rhythm)/34ml/m2 (AF) or LVMI≥115(male)/95(female) g/m2
- meet one the following
- Average E/e'≥ 9
- Septal e' < 7 cm/s
- Lateral e' <10 cm/s
- TR velocity > 2.8 m/s
- PASP > 35 mmHg
- GLS < 16%
Exclusion
Exclusion Criteria:
- systolic blood pressure < 110 mmHg, or heart rate < 60 beats/min
- contra-indication to beta-blockers
- creatinine> 2.4mg/dL
- amyloidosis, hypertrophic cardiomyopathy with obstruction, severe aortic or mitralvalve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCIwithin 3 months before
- AST/ALT >3 x normal upper range
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 17, 2021
Estimated Completion Date:
December 30, 2024
Connect with a study center
Samsung Medical Center
Seoul, Il-won 06351
Korea, Republic ofActive - Recruiting
Wonju Severance Christian Hospital
Wonju, 26426
Korea, Republic ofActive - Recruiting
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